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Impact on Quality of Life in Patients Undergoing Total Gastrectomy or Proximal Gastrectomy for Adenocarcinoma of Esophagogastric Junction

NCT ID: NCT01697917

Last Updated: 2012-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2017-05-31

Brief Summary

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The purpose of this study is to find out more about differences of the quality of life in patients undergoing total gastrectomy or proximal gastrectomy for adenocarcinoma of esophagogastric junction. To find a better reconstruction for patients who received total gastrectomy.

Detailed Description

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Overall, the incidence of stomach cancer worldwide is declining with geographical variation. However, an increase in the incidence rate of adenocarcinoma of esophagogastric junction, called cardia or AEG has been observed in recent years. AEG may represent a specific histopathological and biologic entity. In the treatment AEG there is argument over whether proximal gastractomy(PG) or total gastractomy (TG) should be done. The quality of life (QOL) of the patients following TG or PG arouses people's attention. The purpose of this study was to evaluate differences of the quality of life in patients undergoing total gastrectomy or proximal gastrectomy for adenocarcinoma of esophagogastric junction.

Conditions

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Adenocarcinoma of Esophagogastric Junction.

Keywords

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Adenocarcinoma of Esophagogastric Junction Total Gastrectomy Proximal Gastrectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Total Gastrectomy or Proximal Gastrectomy

Group Type OTHER

Total Gastrectomy or Proximal Gastrectomy

Intervention Type OTHER

Interventions

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Total Gastrectomy or Proximal Gastrectomy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* • Pathologically confirmed gastric malignant tumor at FUSCC (biopsy may be performed at other institutions but slides must be confirmed at FUSCC, as is routine care at our institution), and the patients be assessed can achieve R0 radical dissection through total gastrectomy or proximal gastrectomy by three specialists.

* Patients 20-75 years old
* Normal organ function, able to tolerate surgery, no clear contraindication for surgery
* No evidence of metastases of adjacent organs
* be able to provide follow-up over 2 years
* No specific treatment for gastric cancer before surgery
* In line with the Declaration of Helsinki and the requirements of the hospital ethics committee.
* The subjects were able to understand and comply with the trial protocol, and signed informed consent.

Exclusion Criteria

* • AEG SiewertⅠtype patients

* Synchronous or metachronous (less than five years) and patients with other malignancies.
* Cirrhosis and portal hypertension
* Associated with blood diseases
* Serious heart/ lung and kidney dysfunction or with metabolic diseases such as diabetes, hyperthyroidism.
* Suffering from a serious neurological disease or psychological diseases affecting the life.
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Yanong Wang

Director of Department of Abdominal Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wang Ya Nong, MD, PhD

Role: CONTACT

Phone: +86-21 64175590

Email: [email protected]

Huang Hua, MD,PhD

Role: CONTACT

Phone: +86-21 64175590

Email: [email protected]

Facility Contacts

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Ya Nong Wang, MD,PhD

Role: primary

Hua Huang, MD,PhD

Role: backup

Other Identifiers

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2012-44-562

Identifier Type: -

Identifier Source: org_study_id